US20110213311A1 - Cartridge stopper for an intradermal delivery system - Google Patents
Cartridge stopper for an intradermal delivery system Download PDFInfo
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- US20110213311A1 US20110213311A1 US12/737,453 US73745309A US2011213311A1 US 20110213311 A1 US20110213311 A1 US 20110213311A1 US 73745309 A US73745309 A US 73745309A US 2011213311 A1 US2011213311 A1 US 2011213311A1
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- United States
- Prior art keywords
- stopper
- driving member
- cartridge
- cavity
- spinner
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M5/31515—Connection of piston with piston rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/31573—Accuracy improving means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2403—Ampoule inserted into the ampoule holder
- A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
- A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
- A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
- A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
Definitions
- the present invention relates to a cartridge stopper used in an intradermal delivery system. More particularly, the present invention relates to a cartridge stopper that releasably receives a driving member, thereby improving dose accuracy and reducing “drooling” of the medicament.
- tissue areas such as the intramuscular tissue layer, the subcutaneous tissue layer, and the intradermal tissue layer.
- tissue areas such as the intramuscular tissue layer, the subcutaneous tissue layer, and the intradermal tissue layer.
- tissue layers has specific characteristics that affect the amount of fluid pressure needed to inject a fluid into the targeted tissue layer.
- the user When injecting fluids into each of these tissue layers, the user must exert enough force on the injection device to overcome different amounts of backpressure associated with the particular tissue layer.
- practitioners and self-injectors such as diabetics, are familiar with the force necessary to inject fluids into the subcutaneous layer. Injections into the subcutaneous and intramuscular tissue layers can cause discomfort to the patient or self-injector because of the characteristics of the tissue, needle length and needle diameter or gauge. It is desirable to employ shorter, smaller gauge needles to achieve delivery into the intradermal tissue layer.
- the fluid dynamics of the injection device changes. Additionally, the fluid dynamics between the injection device and the targeted tissue layer also change because the shorter needle length injects the fluid into a different tissue layer, such as the intradermal layer. Because the tissue density between the intramuscular, subcutaneous, and intradermal tissue layers varies, the ease with which fluid may be injected into each type of tissue layer varies. The variation in tissue density causes changes in the backpressure exerted by the tissue against the fluid when it is injected. For instance, the backpressure associated with the intradermal tissue layer is greater than the backpressure associated with the subcutaneous tissue layer.
- pen injection systems are commercially available for subcutaneous substance delivery of medication. These pen injection systems typically use 29 to 31 gauge needles having lengths of between 5 mm and 12.7 mm, and are used to deliver the contents of a medicament cartridge, such as insulin, to the subcutaneous tissue layers of a patient rapidly and conveniently.
- the medicament cartridges are generally of a standard volume and size (including a fixed cross sectional area). The pressure of delivery is the quotient of the actuation force exerted by a user and the cross sectional area of the cartridge. Because the cross-sectional area of the cartridge is fixed, higher delivery pressures require higher actuation forces by the user.
- a “microneedle” pen system has been developed that reduces the pain and sensation to the user normally experienced with subcutaneous substance delivery.
- Such “microneedle” drug delivery systems may include shorter needles, typically less than or equal to 3 mm, with smaller diameters, in the range of 30 to 34 gauge or thinner.
- Such needle length and gauge size combinations are desirable to provide for sharp, yet short, point geometries that can more accurately target substance delivery to only certain selected tissue, such as the deep intradermal or shallow subcutaneous tissue layers, thereby permitting controlled fluid delivery.
- the depth accuracy of the injection To achieve effective medication delivery to the targeted tissue layer in light of higher backpressures, it is desirable to control two factors: the depth accuracy of the injection and the rate of the injection.
- the delivery of medicament within the narrow depth range of the intradermal tissue layer should first be assured, and maintained during injection. Once the depth accuracy is obtained, the rate of injection should be controlled to minimize or eliminate leakage of the medicament into other tissue layers or back out through the skin. Additional details of intradermal drug delivery and microneedles have been previously described in U.S. Pat. No. 6,494,865, issued on Dec. 17, 2002, U.S. Pat. No.
- the intradermal tissue layer of the skin is considerably denser than the subcutaneous tissue region.
- the density of the intradermal tissue layer on a particular patient is, in part, a function of the patient's collagen make-up, which is affected by the patient's age, and the location of the injection site on the patient's body.
- This increased density of the intradermal tissue layer can create a greater backpressure resistance on the injection device than the resistance created when injecting into the subcutaneous tissue region.
- the user or patient would need to exert greater actuation force (which could be substantial) on the injector device actuator or employ some sort of powered injector device.
- the injector device must be designed to withstand the greater backpressure from the intradermal injection site as well as the additional force exerted by the user or patient. Further, the increased actuation force required to actuate the injector device may result in the fluid “jetting” past the desired tissue depth due to the increased fluid pressure.
- Conventional pen-type injection systems may require that the user keep the needle seated in the skin for a period of up to about 10 seconds, after the injection has been completed, to allow for the “axial compliance” of the pen mechanism (or lead screw) and the cartridge back-end stopper to equilibrate to minimize “drool” from the needle tip upon withdrawal. Such time periods may need to be increased to accommodate any additional axial compliance resulting from higher backpressures.
- the back pressure is high for intradermal delivery.
- This high pressure poses a challenge for dose accuracy, which is important for certain drug therapy, such as insulin.
- One of the resulting problems is the compressibility of the cartridge stopper, which is contributes to dose inaccuracy.
- Existing devices overcome this problem by adding a hard core inside the cartridge stopper.
- this solution results in manufacturing problems.
- the conventional stopper 15 is generally a solid member made of a rubber material. An end of the lead screw 7 abuts an end of stopper 15 within the cartridge 2 .
- axial displacement of the lead screw 7 and stopper 15 during dose delivery results in high compression of the stopper 15 , thereby resulting in inaccurate doses.
- a stopper allows a driving member to nest inside the stopper as the hard core to increase the effective hardness of the cartridge stopper.
- the stopper according to an exemplary embodiment of the present invention reduces deformation in cartridges, syringes and other equivalent delivery systems that encounter high pressures, such as back pressures, from intradermal injections, from the use of a thin needle gage, from the injection of viscous liquid, or from a high speed injection.
- the shape of the stopper allows the delivery device driving mechanism to mate inside the stopper, thereby giving the stopper support while also allowing the plunger to be “self-centering” because of the tapered walls.
- the volume compression is reduced without changing materials. This allows the stopper according to an exemplary embodiment of the present invention to be made of currently approved stopper materials that are validated for long-term insulin contact.
- FIG. 1 is a perspective view of an assembled existing pen injector assembly
- FIG. 2 is an exploded perspective view of the components of the pen needle assembly of FIG. 1 ;
- FIG. 3 is a perspective view of an existing stopper for the pen needle assembly of FIGS. 1 and 2 ;
- FIG. 4 is a perspective view in cross section of the stopper of FIG. 3 disposed within a cartridge of the pen needle assembly of FIGS. 1 and 2 ;
- FIG. 5 is an illustration of the compression of the stopper of FIG. 3 ;
- FIG. 6 is an illustration of the compression of a stopper according to an exemplary embodiment of the present invention.
- FIG. 7 is a perspective view in cross section of a stopper according to an exemplary embodiment of the present invention disposed within a cartridge of the drug delivery pen of FIGS. 1 and 2 ;
- FIG. 8 is an elevational view of the stopper of FIG. 7 ;
- FIG. 9 is an elevational view of the stopper of FIG. 8 taken along line 9 - 9 ;
- FIG. 10 is an elevational view of the driving member according to an exemplary embodiment of the present invention.
- FIGS. 11 and 12 are perspective and elevational views, respectively, of the stopper and driving member according to an exemplary embodiment of the present invention.
- FIG. 13 is an elevational view of the stopper and driving member of FIGS. 11 and 12 disposed in a cartridge;
- FIG. 14 is a perspective view of a stopper having a tapered cavity
- FIG. 15 is a perspective view of the stopper and driving member according to an exemplary embodiment of the present invention.
- FIG. 16 is a perspective view of the stopper having O-rings disposed on an outer surface thereof;
- FIGS. 17 and 18 are perspective and cross-sectional views, respectively, of a stopper having a substantially cylindrical cavity
- FIG. 19 is a perspective view of the stopper and driving member according to an exemplary embodiment of the present invention.
- FIG. 20 is a graph of compression caused by force in various delivery devices
- FIG. 21 is a stress-strain curve for a stopper material used in a drug therapy cartridge, such as insulin cartridge for various delivery devices;
- FIGS. 22 and 23 are finite element analysis graphs before and after the application of pressure to a stopper according to an exemplary embodiment of the present invention
- FIGS. 24 and 25 are finite element analysis graphs before and after the application of pressure to an existing stopper
- FIG. 26 is a graph of the vertical displacement of the stopper bottom for an existing stopper
- FIG. 27 is a graph of the vertical displacement of the stopper bottom for a stopper according to an exemplary embodiment of the present invention.
- FIG. 28 is an elevational view in cross section of a drug delivery pen having a stopper and driving member according to an exemplary embodiment of the present invention
- FIG. 29 is an elevational view in cross section of the drug delivery pen of FIG. 28 in which the cap is removed and the needle hub;
- FIG. 30 is an elevational view in cross section of the drug delivery pen of FIG. 29 in which the needle hub, cartridge and outer sleeve are separated;
- FIG. 31 is an elevational view in cross section of the drug delivery pen of FIG. 30 in which the stopper has an insert.
- Pen injector devices such as the exemplary drug delivery pen 100 , as shown in FIGS. 1 and 2 , typically comprise a dose knob/button 24 , an outer sleeve 13 , and a cap 21 .
- the dose knob/button 24 allows a user to set the dosage of medication to be injected.
- the outer sleeve 13 is gripped by the user when injecting medication.
- the cap 21 is used by the user to securely hold the drug delivery pen 100 in a shirt pocket, purse or other suitable location.
- FIG. 2 is an exploded view of an exemplary drug delivery pen shown in FIG. 1 .
- the dose knob/button 24 has a dual purpose and is used to both set the dosage of the medication to be injected and used to inject the dosed medicament via the lead screw 7 and stopper 15 ( FIG. 3 ) through the medicament cartridge 12 attached to the invention through the hub or reservoir housing 20 .
- the dosing and delivery mechanisms are all found within the outer sleeve 13 and are not described in greater detail here as they are understood by those knowledgeable of the prior art.
- the medicament cartridge 12 is typically attached to a standard pen injector housing via known attachment means, such as 1 ⁇ 4 turn fastening features. The distal movement of the plunger or stopper 15 within the medicament cartridge 12 , as shown in FIG.
- an outer shield 69 which attaches to the reservoir housing 20 , covers the reservoir housing.
- An inner shield 59 covers the patient needle 11 within the outer shield 69 .
- the inner shield 59 can be secured to the reservoir housing 20 to cover the patient needle 11 by any suitable means, such as an interference fit or a snap-fit.
- the outer shield 69 and inner shield 59 are removed prior to use.
- the cap 21 fits snugly against outer sleeve 13 to allow a user to securely carry the drug delivery pen 100 .
- the medicament cartridge 12 is typically a glass tube sealed at one end with the septum 16 and sealed at the other end with the stopper 15 .
- the septum 16 is pierceable by a septum penetrating cannula (not shown), but does not move with respect to the medicament cartridge 12 .
- the stopper 15 is axially displaceable within the medicament cartridge 12 while maintaining a fluid tight seal.
- an existing stopper 15 has a solid, planar top surface against which an end of the lead screw 7 abuts.
- such a configuration of the stopper 15 and lead screw 7 results in high compression of the stopper, as shown in FIG. 5 , thereby resulting in inaccurate doses and “drooling” from the needle 11 .
- FIGS. 6-14 and 28 - 30 An exemplary embodiment of the present invention is shown in FIGS. 6-14 and 28 - 30 .
- the cartridge 112 is shown in FIGS. 7 , 13 and 28 - 30 .
- a volume 111 is defined between a first end 110 and a second end 114 and is adapted to receive a medicament.
- the septum 16 ( FIG. 2 ) is disposed at the first end 110 of the cartridge 112 , and the stopper 115 is disposed proximal the second end 114 of the cartridge, thereby sealing the volume 111 .
- the cartridge 112 has an inner surface 113 .
- the driving member 121 has a first end 126 and a second end 128 . As shown in FIGS. 7 and 13 , the first end 126 of the driving member 121 is disposed in the cartridge 112 and the second end 128 is disposed outside of the cartridge.
- the driving member 121 includes a drive screw 127 with a spinner 123 connected thereto. As shown in FIG. 29 , the drive screw 127 has a pin mating inside the spinner 123 , thereby allowing the spinner to freely rotate.
- a stopper 115 has a substantially frusto-conically shaped cavity 117 , as shown in FIGS. 6 , 7 , 9 , 11 - 14 , 19 and 28 - 31 .
- the plunger or driving member 121 has a mating substantially frusto-conically shaped spinner 123 with a flange 125 that substantially corresponds to the stopper cavity 117 .
- the stopper 115 has a first end 141 and a second end 143 .
- the stopper is slidably (axially) disposed in the cartridge 112 , as shown in FIGS. 7 , 13 , 28 and 29 .
- An outer surface 145 of the stopper 115 abuts the inner surface 113 of the cartridge 112 .
- the cavity 117 is accessed through the first end 141 of the stopper 115 .
- a recess 147 may be formed in the outer surface 145 of the stopper 115 to receive an O-ring 131 ( FIG. 16 ).
- the cavity 117 may have a substantially frusto-conical shape as shown in FIGS. 9 and 14 , a substantially cylindrical shape as shown in FIGS. 15 , 17 and 18 , or any other suitable shape.
- FIGS. 28-30 are elevational views in cross section of a drug delivery 200 including a stopper 115 and driving member 121 according to an exemplary embodiment of the present invention.
- the dose knob/button 224 has a dual purpose and is used to both set the dosage of the medication to be injected and used to inject the dosed medicament via the driving member 121 and stopper 115 through the medicament cartridge 112 and through the hub or reservoir housing ( FIG. 2 ).
- the distal movement of the stopper 115 within the medicament cartridge 112 causes medication to be forced into the reservoir housing 20 .
- the medicament cartridge 12 is sealed by septum 16 , which is punctured by a septum penetrating needle cannula 11 located within reservoir housing.
- Reservoir housing 20 is preferably screwed onto the medicament cartridge 112 , although other attachment means can be used.
- the cap 221 fits snugly against outer sleeve 213 to allow a user to securely carry the drug delivery pen 200 .
- the drive screw 127 moves the stopper 115 axially in the cartridge 112 toward the first end 110 of the cartridge 112 , as shown in FIGS. 28 and 29 .
- the drive screw 127 is moved axially in the direction of the second end 114 of the cartridge 112 , thereby separating the spinner 123 from the stopper cavity 117 , as shown in FIG. 30 .
- the cartridge 112 and stopper 115 may be discarded in an appropriate manner.
- the stopper 115 reduces deformation in cartridges, syringes and other equivalent delivery systems that encounter high pressures, such as back pressures, from intradermal injections, from the use of a thin needle gage, from the injection of viscous liquid, or from a high speed injection.
- the shape of the stopper 115 allows the driving member 121 to mate inside of the stopper 115 , thereby giving the stopper support while at the same time allowing the driving member 121 to be “self-centering” because of the tapered walls.
- the stopper 115 may be made of currently approved stopper materials that are validated for long-term insulin contact.
- the shape of the stopper changes driving of the stopper from “pushing” to “pulling” as illustrated in FIGS. 5 and 6 , thereby minimizing the volume of the material compressed.
- the shape of the stopper increases the effective hardness of the stopper 115 by utilizing a mating spinner 123 as the hard core component. Therefore, one advantage is that the volume compression under high pressure is reduced, as shown in FIG. 6 , thereby increasing delivery dose accuracy, which is important for insulin or other dosage critical drug delivery. By maintaining the overall part count, a good economic benefit is provided.
- the spinner 123 is substantially frusto-conically shaped to provide a “self-centering” function when mated with the stopper cavity 117 . This ensures axial alignment of the stopper 115 and driving member 121 .
- the spinner 123 has a wider base proximal the drive screw 127 than at the free end 124 , thereby facilitating removal of the spinner from the stopper 115 .
- a flange 125 may be disposed between the spinner 123 and the drive screw 127 to increase the contact area with the stopper 115 to further reduce the stopper deformation under high pressure.
- the rigid inner spinner 123 prevents the stopper 115 from collapsing under high pressure. Furthermore, the cartridge 112 to stopper 115 surface contact for proper sealing is maintained.
- the stopper has a cavity wall that is substantially straight (i.e., a cylindrically shaped cavity) and a mating plunger spinner that is substantially cylindrical, as shown in FIGS. 15 , 17 and 18 .
- the driving member 121 does not have a flange.
- a rigid stopper has a semi-rigid or flexible O-ring 131 disposed on an outer surface 145 of the stopper 115 to further increase the effective hardness of the stopper, thereby reducing the compressibility of the stopper.
- the O-ring 131 also enhances the sealing property of the stopper 115 so that the overall height of the stopper may be reduced without compromising sealing capability. By reducing the overall height of the stopper 115 , the volume compression of the stopper is further reduced, thereby improving the dose accuracy.
- a harder material insert 171 is disposed inside the stopper 115 in the cavity 117 but not enclosed in the outer softer material, as shown in FIG. 31 .
- the outer material of the stopper 115 is softer for proper sealing.
- the inside second harder material of the insert 171 has a corresponding surface to mate with the spinner 123 of the driving member 121 . This second material may be almost incompressible.
- the stopper of FIG. 17 reduces the effective compressibility and, therefore, increases dose accuracy.
- the initial breakout pressure may be as high as 200 psi, or higher in some applications, and the typical equilibrium pressure is between approximately 30-50 psi.
- Table I one unit of dose accuracy is achieved with a stopper according to an exemplary embodiment of the present invention.
- the existing stopper design as shown in FIGS. 3 and 4 , does not meet application dose accuracy requirements, as shown in Table I.
- Table I indicates the improved dose accuracy between the existing stopper and the stopper according to an exemplary embodiment of the present invention.
- FIGS. 22 and 23 and an existing stopper results of finite element analyses of a stopper according to an exemplary embodiment of the present invention are shown in FIGS. 22 and 23 and an existing stopper in FIGS. 24 and 25 .
- FIGS. 22 and 24 show the stoppers prior to application of pressure and
- FIGS. 23 and 25 show the stoppers after the application of pressure.
- a stopper according to an exemplary embodiment of the present invention deformed significantly less than an existing stopper.
Abstract
Description
- This application claims the benefit under 35 U.S.C. §119(e) of provisional application Ser. No. 61/082,041, filed Jul. 18, 2008, the entire disclosure of which is hereby incorporated by reference.
- The present invention relates to a cartridge stopper used in an intradermal delivery system. More particularly, the present invention relates to a cartridge stopper that releasably receives a driving member, thereby improving dose accuracy and reducing “drooling” of the medicament.
- In certain circumstances, it is desirable to inject medication directly into human tissue. Typically, syringes are used to inject medicaments into tissue areas, such as the intramuscular tissue layer, the subcutaneous tissue layer, and the intradermal tissue layer. Each of these tissue layers has specific characteristics that affect the amount of fluid pressure needed to inject a fluid into the targeted tissue layer. When injecting fluids into each of these tissue layers, the user must exert enough force on the injection device to overcome different amounts of backpressure associated with the particular tissue layer. In general, practitioners and self-injectors, such as diabetics, are familiar with the force necessary to inject fluids into the subcutaneous layer. Injections into the subcutaneous and intramuscular tissue layers can cause discomfort to the patient or self-injector because of the characteristics of the tissue, needle length and needle diameter or gauge. It is desirable to employ shorter, smaller gauge needles to achieve delivery into the intradermal tissue layer.
- It is noted that when the needle lengths are shortened and needle diameters are made smaller, the fluid dynamics of the injection device changes. Additionally, the fluid dynamics between the injection device and the targeted tissue layer also change because the shorter needle length injects the fluid into a different tissue layer, such as the intradermal layer. Because the tissue density between the intramuscular, subcutaneous, and intradermal tissue layers varies, the ease with which fluid may be injected into each type of tissue layer varies. The variation in tissue density causes changes in the backpressure exerted by the tissue against the fluid when it is injected. For instance, the backpressure associated with the intradermal tissue layer is greater than the backpressure associated with the subcutaneous tissue layer.
- Currently, several pen injection systems are commercially available for subcutaneous substance delivery of medication. These pen injection systems typically use 29 to 31 gauge needles having lengths of between 5 mm and 12.7 mm, and are used to deliver the contents of a medicament cartridge, such as insulin, to the subcutaneous tissue layers of a patient rapidly and conveniently. The medicament cartridges are generally of a standard volume and size (including a fixed cross sectional area). The pressure of delivery is the quotient of the actuation force exerted by a user and the cross sectional area of the cartridge. Because the cross-sectional area of the cartridge is fixed, higher delivery pressures require higher actuation forces by the user.
- A “microneedle” pen system has been developed that reduces the pain and sensation to the user normally experienced with subcutaneous substance delivery. Such “microneedle” drug delivery systems may include shorter needles, typically less than or equal to 3 mm, with smaller diameters, in the range of 30 to 34 gauge or thinner. Such needle length and gauge size combinations are desirable to provide for sharp, yet short, point geometries that can more accurately target substance delivery to only certain selected tissue, such as the deep intradermal or shallow subcutaneous tissue layers, thereby permitting controlled fluid delivery. Current typical pen injection systems used for subcutaneous delivery are not believed optimal for use by the general population of self-injectors for delivery into the intradermal layer because of, inter alia, the high backpressures associated with injecting fluid into the intradermal layers of the skin using microneedles.
- To achieve effective medication delivery to the targeted tissue layer in light of higher backpressures, it is desirable to control two factors: the depth accuracy of the injection and the rate of the injection. This is of particular interest in connection with intradermal injections because the backpressures are relatively high, but similar analysis can be applied when injecting into the intramuscular or the subcutaneous tissue layers. The delivery of medicament within the narrow depth range of the intradermal tissue layer should first be assured, and maintained during injection. Once the depth accuracy is obtained, the rate of injection should be controlled to minimize or eliminate leakage of the medicament into other tissue layers or back out through the skin. Additional details of intradermal drug delivery and microneedles have been previously described in U.S. Pat. No. 6,494,865, issued on Dec. 17, 2002, U.S. Pat. No. 6,569,143, issued on May 27, 2003, PCT Publication No. WO 2005/025461, published on Mar. 24, 2005, and U.S. Patent Application Publication No. 2005/0065472, published on Mar. 24, 2005, all of which are assigned to Becton, Dickinson and Company, and the entire content of each such patent and application being incorporated herein by reference.
- The intradermal tissue layer of the skin is considerably denser than the subcutaneous tissue region. The density of the intradermal tissue layer on a particular patient is, in part, a function of the patient's collagen make-up, which is affected by the patient's age, and the location of the injection site on the patient's body. This increased density of the intradermal tissue layer can create a greater backpressure resistance on the injection device than the resistance created when injecting into the subcutaneous tissue region. To overcome the increased backpressure resistance when injecting into the intradermal tissue layer with a conventional pen system, the user or patient would need to exert greater actuation force (which could be substantial) on the injector device actuator or employ some sort of powered injector device. In these applications, the injector device must be designed to withstand the greater backpressure from the intradermal injection site as well as the additional force exerted by the user or patient. Further, the increased actuation force required to actuate the injector device may result in the fluid “jetting” past the desired tissue depth due to the increased fluid pressure.
- Conventional pen-type injection systems may require that the user keep the needle seated in the skin for a period of up to about 10 seconds, after the injection has been completed, to allow for the “axial compliance” of the pen mechanism (or lead screw) and the cartridge back-end stopper to equilibrate to minimize “drool” from the needle tip upon withdrawal. Such time periods may need to be increased to accommodate any additional axial compliance resulting from higher backpressures.
- As described above, the back pressure is high for intradermal delivery. This high pressure poses a challenge for dose accuracy, which is important for certain drug therapy, such as insulin. One of the resulting problems is the compressibility of the cartridge stopper, which is contributes to dose inaccuracy. Existing devices overcome this problem by adding a hard core inside the cartridge stopper. However, this solution results in manufacturing problems. Additionally, as shown in
FIGS. 3 and 4 , theconventional stopper 15 is generally a solid member made of a rubber material. An end of thelead screw 7 abuts an end ofstopper 15 within thecartridge 2. However, axial displacement of thelead screw 7 and stopper 15 during dose delivery results in high compression of thestopper 15, thereby resulting in inaccurate doses. - Accordingly, a need exists for an intradermal delivery system that improves dose accuracy and minimizes medicament “drooling”.
- In accordance with an aspect of the present invention, a stopper allows a driving member to nest inside the stopper as the hard core to increase the effective hardness of the cartridge stopper.
- The stopper according to an exemplary embodiment of the present invention reduces deformation in cartridges, syringes and other equivalent delivery systems that encounter high pressures, such as back pressures, from intradermal injections, from the use of a thin needle gage, from the injection of viscous liquid, or from a high speed injection. The shape of the stopper allows the delivery device driving mechanism to mate inside the stopper, thereby giving the stopper support while also allowing the plunger to be “self-centering” because of the tapered walls. By reducing the height (thickness) of the soft rubber in the cartridge and replacing it with the rigid plastic plunger tip, the volume compression is reduced without changing materials. This allows the stopper according to an exemplary embodiment of the present invention to be made of currently approved stopper materials that are validated for long-term insulin contact.
- Objects, advantages, and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.
- The above benefits and other advantages of the various embodiments of the present invention will be more apparent from the following detailed description of exemplary embodiments of the present invention and from the accompanying drawing figures, in which:
-
FIG. 1 is a perspective view of an assembled existing pen injector assembly; -
FIG. 2 is an exploded perspective view of the components of the pen needle assembly ofFIG. 1 ; -
FIG. 3 is a perspective view of an existing stopper for the pen needle assembly ofFIGS. 1 and 2 ; -
FIG. 4 is a perspective view in cross section of the stopper ofFIG. 3 disposed within a cartridge of the pen needle assembly ofFIGS. 1 and 2 ; -
FIG. 5 is an illustration of the compression of the stopper ofFIG. 3 ; -
FIG. 6 is an illustration of the compression of a stopper according to an exemplary embodiment of the present invention; -
FIG. 7 is a perspective view in cross section of a stopper according to an exemplary embodiment of the present invention disposed within a cartridge of the drug delivery pen ofFIGS. 1 and 2 ; -
FIG. 8 is an elevational view of the stopper ofFIG. 7 ; -
FIG. 9 is an elevational view of the stopper ofFIG. 8 taken along line 9-9; -
FIG. 10 is an elevational view of the driving member according to an exemplary embodiment of the present invention; -
FIGS. 11 and 12 are perspective and elevational views, respectively, of the stopper and driving member according to an exemplary embodiment of the present invention; -
FIG. 13 is an elevational view of the stopper and driving member ofFIGS. 11 and 12 disposed in a cartridge; -
FIG. 14 is a perspective view of a stopper having a tapered cavity; -
FIG. 15 is a perspective view of the stopper and driving member according to an exemplary embodiment of the present invention; -
FIG. 16 is a perspective view of the stopper having O-rings disposed on an outer surface thereof; -
FIGS. 17 and 18 are perspective and cross-sectional views, respectively, of a stopper having a substantially cylindrical cavity; -
FIG. 19 is a perspective view of the stopper and driving member according to an exemplary embodiment of the present invention; -
FIG. 20 is a graph of compression caused by force in various delivery devices; -
FIG. 21 is a stress-strain curve for a stopper material used in a drug therapy cartridge, such as insulin cartridge for various delivery devices; -
FIGS. 22 and 23 are finite element analysis graphs before and after the application of pressure to a stopper according to an exemplary embodiment of the present invention; -
FIGS. 24 and 25 are finite element analysis graphs before and after the application of pressure to an existing stopper; -
FIG. 26 is a graph of the vertical displacement of the stopper bottom for an existing stopper; -
FIG. 27 is a graph of the vertical displacement of the stopper bottom for a stopper according to an exemplary embodiment of the present invention; -
FIG. 28 is an elevational view in cross section of a drug delivery pen having a stopper and driving member according to an exemplary embodiment of the present invention; -
FIG. 29 is an elevational view in cross section of the drug delivery pen ofFIG. 28 in which the cap is removed and the needle hub; -
FIG. 30 is an elevational view in cross section of the drug delivery pen ofFIG. 29 in which the needle hub, cartridge and outer sleeve are separated; and -
FIG. 31 is an elevational view in cross section of the drug delivery pen ofFIG. 30 in which the stopper has an insert. - Throughout the drawings, like reference numbers will be understood to refer to like parts, components and structures.
- The following description and details of exemplary embodiments of the present invention, while generally disclosed in a typical drug delivery pen as shown in
FIGS. 1 and 2 , could more broadly apply to a needle and hub assembly for use in conjunction with, or incorporated onto, other injection devices such as syringes and infusion devices. The assembly and operation of a typical drug delivery pen, as shown inFIGS. 1 and 2 , is described in U.S. patent application Ser. No. 11/102,874, which is hereby incorporated by reference in its entirety. - Pen injector devices, such as the exemplary
drug delivery pen 100, as shown inFIGS. 1 and 2 , typically comprise a dose knob/button 24, anouter sleeve 13, and acap 21. The dose knob/button 24 allows a user to set the dosage of medication to be injected. Theouter sleeve 13 is gripped by the user when injecting medication. Thecap 21 is used by the user to securely hold thedrug delivery pen 100 in a shirt pocket, purse or other suitable location. -
FIG. 2 is an exploded view of an exemplary drug delivery pen shown inFIG. 1 . The dose knob/button 24 has a dual purpose and is used to both set the dosage of the medication to be injected and used to inject the dosed medicament via thelead screw 7 and stopper 15 (FIG. 3 ) through themedicament cartridge 12 attached to the invention through the hub orreservoir housing 20. In standard drug delivery pens, the dosing and delivery mechanisms are all found within theouter sleeve 13 and are not described in greater detail here as they are understood by those knowledgeable of the prior art. Themedicament cartridge 12 is typically attached to a standard pen injector housing via known attachment means, such as ¼ turn fastening features. The distal movement of the plunger orstopper 15 within themedicament cartridge 12, as shown inFIG. 4 , causes medication to be forced into thereservoir housing 20. Themedicament cartridge 12 is sealed byseptum 16, which is punctured by a septum penetrating needle cannula (not shown) located withinreservoir housing 20.Reservoir housing 20 is preferably screwed onto themedicament cartridge 12, although other attachment means can be used. To protect a user, or anyone who handles thepen injection device 100, anouter shield 69, which attaches to thereservoir housing 20, covers the reservoir housing. Aninner shield 59 covers thepatient needle 11 within theouter shield 69. Theinner shield 59 can be secured to thereservoir housing 20 to cover thepatient needle 11 by any suitable means, such as an interference fit or a snap-fit. Theouter shield 69 andinner shield 59 are removed prior to use. Thecap 21 fits snugly againstouter sleeve 13 to allow a user to securely carry thedrug delivery pen 100. - The
medicament cartridge 12 is typically a glass tube sealed at one end with theseptum 16 and sealed at the other end with thestopper 15. Theseptum 16 is pierceable by a septum penetrating cannula (not shown), but does not move with respect to themedicament cartridge 12. Thestopper 15 is axially displaceable within themedicament cartridge 12 while maintaining a fluid tight seal. As shown inFIGS. 3 and 4 , an existingstopper 15 has a solid, planar top surface against which an end of thelead screw 7 abuts. However, such a configuration of thestopper 15 andlead screw 7 results in high compression of the stopper, as shown inFIG. 5 , thereby resulting in inaccurate doses and “drooling” from theneedle 11. - An exemplary embodiment of the present invention is shown in
FIGS. 6-14 and 28-30. Thecartridge 112 is shown inFIGS. 7 , 13 and 28-30. Avolume 111 is defined between afirst end 110 and asecond end 114 and is adapted to receive a medicament. The septum 16 (FIG. 2 ) is disposed at thefirst end 110 of thecartridge 112, and thestopper 115 is disposed proximal thesecond end 114 of the cartridge, thereby sealing thevolume 111. Thecartridge 112 has aninner surface 113. - As shown in
FIGS. 7 , 10, 13 and 28-30, the drivingmember 121 has afirst end 126 and asecond end 128. As shown inFIGS. 7 and 13 , thefirst end 126 of the drivingmember 121 is disposed in thecartridge 112 and thesecond end 128 is disposed outside of the cartridge. The drivingmember 121 includes adrive screw 127 with aspinner 123 connected thereto. As shown inFIG. 29 , thedrive screw 127 has a pin mating inside thespinner 123, thereby allowing the spinner to freely rotate. - A
stopper 115 has a substantially frusto-conically shapedcavity 117, as shown inFIGS. 6 , 7, 9, 11-14, 19 and 28-31. The plunger or drivingmember 121 has a mating substantially frusto-conicallyshaped spinner 123 with aflange 125 that substantially corresponds to thestopper cavity 117. - As shown in
FIGS. 8 and 9 , thestopper 115 has afirst end 141 and asecond end 143. The stopper is slidably (axially) disposed in thecartridge 112, as shown inFIGS. 7 , 13, 28 and 29. Anouter surface 145 of thestopper 115 abuts theinner surface 113 of thecartridge 112. Thecavity 117 is accessed through thefirst end 141 of thestopper 115. Arecess 147 may be formed in theouter surface 145 of thestopper 115 to receive an O-ring 131 (FIG. 16 ). Thecavity 117 may have a substantially frusto-conical shape as shown inFIGS. 9 and 14 , a substantially cylindrical shape as shown inFIGS. 15 , 17 and 18, or any other suitable shape. -
FIGS. 28-30 are elevational views in cross section of adrug delivery 200 including astopper 115 and drivingmember 121 according to an exemplary embodiment of the present invention. The dose knob/button 224 has a dual purpose and is used to both set the dosage of the medication to be injected and used to inject the dosed medicament via the drivingmember 121 andstopper 115 through themedicament cartridge 112 and through the hub or reservoir housing (FIG. 2 ). The distal movement of thestopper 115 within themedicament cartridge 112 causes medication to be forced into thereservoir housing 20. Themedicament cartridge 12 is sealed byseptum 16, which is punctured by a septum penetratingneedle cannula 11 located within reservoir housing.Reservoir housing 20 is preferably screwed onto themedicament cartridge 112, although other attachment means can be used. Thecap 221 fits snugly againstouter sleeve 213 to allow a user to securely carry thedrug delivery pen 200. - As doses of the medicament are administered, the
drive screw 127 moves thestopper 115 axially in thecartridge 112 toward thefirst end 110 of thecartridge 112, as shown inFIGS. 28 and 29 . Once the medicament stored in thecartridge volume 111 has been depleted or the cartridge is to be discarded, thedrive screw 127 is moved axially in the direction of thesecond end 114 of thecartridge 112, thereby separating thespinner 123 from thestopper cavity 117, as shown inFIG. 30 . When thespinner 123 andstopper 115 have been separated, thecartridge 112 andstopper 115 may be discarded in an appropriate manner. - The
stopper 115 reduces deformation in cartridges, syringes and other equivalent delivery systems that encounter high pressures, such as back pressures, from intradermal injections, from the use of a thin needle gage, from the injection of viscous liquid, or from a high speed injection. The shape of thestopper 115 allows the drivingmember 121 to mate inside of thestopper 115, thereby giving the stopper support while at the same time allowing the drivingmember 121 to be “self-centering” because of the tapered walls. By reducing the height (thickness) of the soft rubber of thestopper 115 disposed in thecartridge 112 and replacing it with the rigidplastic spinner 123 of the drivingmember 121, the volume compression is reduced without changing materials, as shown inFIG. 6 . Thus, thestopper 115 may be made of currently approved stopper materials that are validated for long-term insulin contact. The shape of the stopper changes driving of the stopper from “pushing” to “pulling” as illustrated inFIGS. 5 and 6 , thereby minimizing the volume of the material compressed. - The shape of the stopper increases the effective hardness of the
stopper 115 by utilizing amating spinner 123 as the hard core component. Therefore, one advantage is that the volume compression under high pressure is reduced, as shown inFIG. 6 , thereby increasing delivery dose accuracy, which is important for insulin or other dosage critical drug delivery. By maintaining the overall part count, a good economic benefit is provided. - The
spinner 123 is substantially frusto-conically shaped to provide a “self-centering” function when mated with thestopper cavity 117. This ensures axial alignment of thestopper 115 and drivingmember 121. Thespinner 123 has a wider base proximal thedrive screw 127 than at thefree end 124, thereby facilitating removal of the spinner from thestopper 115. Also, aflange 125 may be disposed between thespinner 123 and thedrive screw 127 to increase the contact area with thestopper 115 to further reduce the stopper deformation under high pressure. The rigidinner spinner 123 prevents thestopper 115 from collapsing under high pressure. Furthermore, thecartridge 112 tostopper 115 surface contact for proper sealing is maintained. - In another exemplary embodiment of the present invention the stopper has a cavity wall that is substantially straight (i.e., a cylindrically shaped cavity) and a mating plunger spinner that is substantially cylindrical, as shown in
FIGS. 15 , 17 and 18. In another exemplary embodiment, the drivingmember 121 does not have a flange. - In still another exemplary embodiment shown in
FIG. 16 , a rigid stopper has a semi-rigid or flexible O-ring 131 disposed on anouter surface 145 of thestopper 115 to further increase the effective hardness of the stopper, thereby reducing the compressibility of the stopper. The O-ring 131 also enhances the sealing property of thestopper 115 so that the overall height of the stopper may be reduced without compromising sealing capability. By reducing the overall height of thestopper 115, the volume compression of the stopper is further reduced, thereby improving the dose accuracy. - In another exemplary embodiment, a
harder material insert 171 is disposed inside thestopper 115 in thecavity 117 but not enclosed in the outer softer material, as shown inFIG. 31 . The outer material of thestopper 115 is softer for proper sealing. The inside second harder material of theinsert 171 has a corresponding surface to mate with thespinner 123 of the drivingmember 121. This second material may be almost incompressible. The stopper ofFIG. 17 reduces the effective compressibility and, therefore, increases dose accuracy. -
TABLE I Volume (unit) 200 psi 100 psi 50 psi 25 psi 10 psi Existing Stopper 10.5 6.5 3.7 1.7 0.7 Design Stopper According to 2.7 1.6 1 0.5 0.2 Exemplary Embodiment - The initial breakout pressure may be as high as 200 psi, or higher in some applications, and the typical equilibrium pressure is between approximately 30-50 psi. As shown in Table I, one unit of dose accuracy is achieved with a stopper according to an exemplary embodiment of the present invention. The existing stopper design, as shown in
FIGS. 3 and 4 , does not meet application dose accuracy requirements, as shown in Table I. Furthermore, Table I indicates the improved dose accuracy between the existing stopper and the stopper according to an exemplary embodiment of the present invention. - Results of finite element analyses of a stopper according to an exemplary embodiment of the present invention are shown in
FIGS. 22 and 23 and an existing stopper inFIGS. 24 and 25 .FIGS. 22 and 24 show the stoppers prior to application of pressure andFIGS. 23 and 25 show the stoppers after the application of pressure. As clearly shown inFIGS. 23 and 25 , a stopper according to an exemplary embodiment of the present invention deformed significantly less than an existing stopper. - While exemplary embodiments have been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications may be made therein without departing from the scope of the invention as defined in the appended claims.
Claims (22)
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US12/737,453 US9345835B2 (en) | 2008-07-18 | 2009-07-17 | Cartridge stopper for an intradermal delivery system |
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PCT/US2009/004131 WO2010008574A1 (en) | 2008-07-18 | 2009-07-17 | Cartridge stopper for an intradermal delivery system |
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CA2845392A1 (en) * | 2011-09-08 | 2013-03-14 | Sanofi-Aventis Deutschland Gmbh | Securing means for a drug delivery device |
JP6093157B2 (en) * | 2012-11-27 | 2017-03-08 | 住友ゴム工業株式会社 | Syringe design method |
US10245381B2 (en) | 2017-08-21 | 2019-04-02 | Chalbourne Brasington | Two-step auto-injection device |
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JP6032892B2 (en) | 2016-11-30 |
WO2010008574A1 (en) | 2010-01-21 |
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